NCT04859569

Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors

A Phase III Study Comparing Efficacy and Safety of LY01011 and Xgeva®(Denosumab) in Patients With Bone Metastases From Solid Tumors

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter，randomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone metastases from solid tumors.

Detailed description

The primary objective is to evaluate the similarity of clinical efficacy between LY01011 and Xgeva® in patients with bone metastases from solid tumors. The secondary objective is to evaluate the similarity of clinical safety and immunogenicity between LY01011 and Xgeva® in patients with bone metastases from solid tumors. Each subject will participate in the study for 53 weeks. Treatments are administered on day 1 and Q4W thereafter through week 49. All patients are instructed to take 500 mg calcium and 400 IU vitamin D daily.

Conditions

• Bone Metastases From Solid Tumors

Interventions

Type	Name	Description
DRUG	LY01011	subcutaneously (SC) once every 4 weeks (Q4W)
DRUG	Xgeva®	subcutaneously (SC) once every 4 weeks (Q4W)

Timeline

• Start date: 2021-04-30
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2021-04-26
• Last updated: 2021-06-07

Locations

1 site across 1 country: China